MAUDE Adverse Event Report: MDT PUERTO RICO OPERATIONS CO SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-40

Device Problems Difficult to Interrogate (1331); Pumping Stopped (1503); Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896); Inappropriate or Unexpected Reset (2959); Protective Measures Problem (3015)

Patient Problems Muscular Rigidity (1968); Therapeutic Response, Decreased (2271)

Event Date 07/17/2017

Event Type  Injury  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) via a company representative regarding a patient who was receiving gablofen 20000; 250mcg via an implantable pump.Indication for use was intractable spasticity and multiple sclerosis.The patient weight and medical history were asked and will not be made available.The date of the event was (b)(6) 2017.It was reported a pump malfunction occurred.The critical alarm was sounding.The pump was interrogated and the pump went into safe state mode and reduced the dose to minimum rate.The patient experienced withdrawal symptoms of increased spasticity.The pump was updated with the correct dose of 250 mcg a day.The patient was prescribed oral baclofen.The issue was not resolved.There were no environmental/external/patient factors that may have led or contributed to the issue.Surgical intervention was planned but was not scheduled.The patient will have the pump replaced.Patient status was alive - no injury.No further complications were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a manufacturing representative.The pump was updated and restarted.They were unsure if/when it would stall again.It was clarified that the term ¿stall¿ was in reference to the pump going into safe state mode.The patient was given oral baclofen to treat any increased spasticity/withdrawal.The pump was going to be replaced.However, a date had not been scheduled as of yet (as of (b)(6)2017.It would ¿hopefully be on the surgeon¿s schedule within the next three weeks¿.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a manufacturer representative on 2017-aug-09.It was reported that the pump was replaced on (b)(6) 2017 and was to be sent back for analysis.On the day the pump was replaced, an alarm was reportedly heard.When they read the pump, it said "telemetry aborted," then "reset occurred.Incompatible version.This pump was programmed by version.Cannot determine last version.Version in this programmer is v.6.Record this information." the pump off password was provided to disable the pump and silence the alarms.

Manufacturer Narrative

Evaluation of implantable pump serial number (b)(4) revealed a high battery resistance during functional testing in the lab.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.

Event Description

Additional information was received from a company representative (rep) via the return paperwork for the pump and the pump logs were provided.The current pump settings were examined at (b)(6)2017 (last change (b)(6)2016) showed a reset occurred, the pump and was in safe state, and ¿stopped pump period may exceed tube set¿ message was encountered.The session data report indicated the low reservoir alarm had occurred and confirmed the pump was in minimum rate mode.No further complications were reported/anticipated or expected.Additional information was received on 2017-aug-23.It was reported that the programmer had a current version application card in it, and the version issues were related to the reset.The manufacturer's representative was the last person to interrogate the pump when the event occurred.No further complications were reported.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer (Section G): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6743330
• MDR Text Key: 81002154
• Report Number: 3004209178-2017-15558
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2012
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-3043-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR